AIM HY-INFORM

Comparison of Optimal Hypertension RegiMens (Part of the Ancestry Informative Markers in Hypertension Programme)

 

Research summary

Ancestry and biological Informative Markers for stratification of Hypertension (The AIM HY Study) is a stratified medicine consortium grant, funded by Medical Research Council and British Heart Foundation, which involves 26 investigators over 11 institutions in the UK and US. AIM HY will investigate whether genetic markers of ancestry (which predict the proportion of a person’s ancestors from Europe, Asia and Africa), combined with detailed information about the chemical makeup of their blood, can predict the best type of drug or combination of drugs for that person. The ultimate aim is to deliver personalised treatment for high blood pressure, based on a single blood test that captures the genetic and other biological factors that determine how an individual will respond.  This should reduce the number of consultations; the time required to achieve optimal blood pressure control and contribute to better hypertension control in the UK.

The rationale for the clinical trial is to provide an optimal choice of anti-hypertensive therapy from existing first-line-drugs (and differing combinations thereof) in a multi-ethnic population in the UK. This is predicated on current evidence largely from non-UK cohorts that there are differences in treatment response to antihypertensive drugs which vary between self-declared black and white individuals. A statistical learning approach will be applied to formulate the optimal panel of predictors for the response to first-line drugs from existing data. We will then use this to test prediction of response to first-line drugs and drug combinations in a RCT in the current study. This will be done prospectively but with the option of refining the prediction in a further discovery phase.

Output from the trial will provide the first prospective evidence for best treatment choice according to SDE for White, Black and Asian populations in the UK. This should reduce the number of consultations; time required to achieve optimal blood pressure control and the contribution to better hypertension control in the UK. Future studies will look to see if outcomes from this trial could be applied to other ethnic groups or mixed ethnic populations.

aimhy.org.uk

clinicaltrials.gov

Main inclusion criteria

To be included in the trial the participant must:

  1. Have given written informed consent to participate

  2. Be aged 18 to 65 years inclusive

  3. Self-Define Ethnicity: participants should SELF IDENTIFY into 1 of the three groups below:

    White: White British, White Irish, Any other white background
    Black or Black British: Black Caribbean, Black African, Any other black background
    Asian or Asian British: Asian Indian, Asian Pakistani, Asian Bangladeshi, Any other Asian background

  4. Be hypertensive defined as:- Mono-therapy rotation

    1. Currently untreated with EITHER

      1. an ABPM day time average blood pressure ≥ 135mmHG (systolic) or ≥ 85mmHg (diastolic) OR

      2. Home BP measurements using a validated device based on the average of 10 blood pressure readings of ≥135 mmHg (systolic) or ≥85 mmHg (diastolic)

    2. Patients who may be taking antihypertensive drugs at sub therapeutic doses or in ineffective combinations, and who are felt likely to be controllable on a study drug and willing and able to be washed out, at the discretion of the CI (Chief Investigator) / PI (Principal Investigator), can enter the trial if they meet the above criteria.

    3. Dual therapy rotation: Treated hypertensive receiving one to three antihypertensive drugs with a blood pressure (ABPM daytime average blood pressure or Home BP as in a.) between 135 or 200 mmHg (systolic) AND between 85 or 110 mmHg (diastolic).

Main exclusion criteria

The presence of any of the following will mean participants are ineligible:

  1. Participant does not fit into one of the defined ethnic groups e.g. Mixed

  2. Pregnant or breastfeeding women

  3. Known or suspected secondary hypertension

  4. Significant sensitivity or contraindications to any of the study medications

  5. Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses

  6. Requirement to take any of the study drugs continuously e.g. ACEi and heart failure

  7. Any clinically significant hepatic impairment

  8. Any clinically significant kidney impairment

  9. Concurrent participation in another clinical trial using systemic vasoactive medications or medications known to interact with the study drugs (participation in another study as part of the AIM HY mechanistic or social science programme will not be an exclusion criterion)

  10. Patients who are deemed unsuitable by the investigator on clinical grounds e.g. an abnormal heart rhythm due to Atrial Fibrillation (AF)

Chief investigator

Professor Ian Wilkinson

Contact details

Senior Clinical Trials Coordinator: Heike Templin

Telephone: 01223 250874 | Email: [email protected]